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Sumagen Canada Inc. and Western University of Ontario announced today. The vaccine, which was developed by Dr. Chil-Yong Kang and his team, is the first genetically modified, whole-killed vaccine to be approved for testing in humans.

“We are now prepared to take the next steps towards Phase 2 and Phase 3 clinical trials,” stated Jung-Gee Cho, the CEO of Sumagen Co. Ltd., in a press release. “We are opening the gate to pharmaceutical companies, government, and charity organization for collaboration to be one step closer to the first commercialized HIV vaccine."

That's a rather liberal use of the word horizon. They just finished a phase 1 study showing its safe. They still need to complete phase 2 and 3 studies and actually prove that it works. That's quite a high bar to pass.

You know I had a conversation with my ASO director the other day about their fund raising goals. I was asking how I could put in cash and check donations on my fundraising page. She jump to the conclusion that I was looking to recognized for my efforts. I had to stop her and say no, no, no... I want to recognize those people who supported myself in helping me help others.

At least I started this thread in the other forum as it may offer a glimpse of hope. Some times that is all people have to hold onto is hope. Maybe the other poster should added a "?" mark on their tile, However I will point out that we already have negativity in this thread and it makes me sad.

"And so we remained till the red of the dawn began to fall through the snow gloom. I was desolate and afraid, and full of woe and terror. But when that beautiful sun began to climb the horizon life was to me again-Bram Stoker"

"A dream is the bearer of a new possibility, the enlarged horizon, the great hope-Howard Thurman"

That's a rather liberal use of the word horizon. They just finished a phase 1 study showing its safe. They still need to complete phase 2 and 3 studies and actually prove that it works. That's quite a high bar to pass.

...At least I started this thread in the other forum as it may offer a glimpse of hope. Some times that is all people have to hold onto is hope. Maybe the other poster should added a "?" mark on their tile, However I will point out that we already have negativity in this thread and it makes me sad.

Hey aaware72,

Bug mentioning that the vaccine has not completed phase 2 and 3 studies, is not negativity, just reality.

I will admit that for the most part all of this subject matter is new to me and I'm trying to absorb and filter through it all and what it means.

As someone who is new to all this you need to read past the headlines. My comment was with the use of the term "HIV Vaccine on the horizon." That makes it sound like its just around the corner, maybe within a year?? However, that's not the case. When you read the details you see that this is a phase 1 study which is just determining if the vaccine is safe. They haven't even started to study if the vaccine actually works. Thats the hard part. Phase 2 and 3 studies can take years if not a decade or more. AND most trials fail in phase 2 or 3. Thats just reality. So YES, there is some negativity but its on how these studies are reported in the press. They are written to make headlines and get people to read them and in many cases they are misleading (and often times end up causing frustration in people with HIV who dont understand the process).

I urge you to learn about HIV research, how its conducted, and what it all means. Once you do you will quickly learn just how misleading some stories are and who you can and cannot trust when it comes to HIV research. There is a lot of garbage written about it, but there is also a lot of really interesting and worthwhile work being conducted.

I am probably one of the most ardent supporters and cheerleaders of HIV research. There is a lot of great science that is being conducted. I recently went to a conference about some research into trying to cure HIV sponsored by the NIH. I'm not trying to put a downer on the story. Its great that they are trying a different approach in their vaccine and I hope that it succeeds. Its just not "on the horizon" as the headline makes it appear.

As someone who is new to all this you need to read past the headlines. My comment was with the use of the term "HIV Vaccine on the horizon." That makes it sound like its just around the corner, maybe within a year??

I will say, I simply used the title of the original article and posted it as an interesting new development. As for horizon I don't believe there is a definition out there that says it is within one year, but I agree that a better title might have been "HIV Vaccine maybe on horizon" I also understand and agree with you on clinical trials. Passing a phase I trial great, but phase II & III are the real challenges. I would also add that the FDA requires a higher standard of proof of efficacy before approval than what is required in most countries. Lastly I generally think of the glass half full verses, half empty and the optimist in me believes that with all developments in the treatment HIV/AIDS we will see a vaccine in my lifetime.

In reading my last post, I think when it comes to our posts maybe we should, at least in research & developments, stick to educating with our posts, verses stating our opinions for those who are new and are trying to filter the facts from fiction.

I will admit that for the most part all of this subject matter is new to me and I'm trying to absorb and filter through it all and what it means.

I understand there is still other phases to go and lets hope for the best. Have there been other studies and research that have made it this far before? When I read this about these trials:

"is the first genetically modified, whole-killed vaccine to be approved for testing in humans."

That sounds like a big deal to me. No?

In a way it is big news, but fruition of this will be at least a decade away. I don't mean to be testy sometimes, but they have been claiming a cure for HIV for at least three decades. I think it's great that we promote hope, however that hope must be tempered with reality. I don't want to mislead folks into thinking that a vaccine is right around the corner. Sometimes it's really hard to balance the hope with the harsh realities.

In reading my last post, I think when it comes to our posts maybe we should, at least in research & developments, stick to educating with our posts, verses stating our opinions for those who are new and are trying to filter the facts from fiction.

I think it was tested on HIV+ people since it was a dead, whole virus and they wanted to make sure it wouldn't give you HIV. I think they figured it couldn't do any harm to people that were already poz.

Still -- it did get people to produce antibodies -- maybe it could be of some benefit to us.

Phase I Clinical Trial (SAV CT 01) of the first and only preventative HIV vaccine based on a genetically modified killed whole virus (SAV001-H) has been successfully completed with no adverse effects in all patients

I think it was tested on HIV+ people since it was a dead, whole virus and they wanted to make sure it wouldn't give you HIV. I think they figured it couldn't do any harm to people that were already poz.

Still -- it did get people to produce antibodies -- maybe it could be of some benefit to us.

It seems like a long way off -- but it's a good start.

Yeah, that makes sense. And yes, there may be some benefits for us too. But if this is a preventive vaccine, eventually, they will have to do a large scale trial on HIV negative people - similar to the Thai trial years ago, don't they?How else could they determine how effective the vaccine will protect people?

Im having problems finding what led me to believe its a therapeutic vaccine but the quote below also leads to me believe that it is a preventative and therapeutic vaccine .

I guess I misunderstood because after further reading I see its preventative only .

These pseudovirions, carrying many important regions of both internal proteins and external envelope proteins of AIDS virus, will be used to generate the neutralizing antibodies which will prevent the virus infection and also generate cytotoxic T lymphocytes, which are designed to kill and destroy the AIDS virus-infected cells in the body.

I think preliminary observations hint that it could be useful as both a preventative and therapeutic vaccine as it targets two separate antigens (one that's prominent during new infections and another that's there throughout infection).

After receiving the vaccination, volunteers visited test sites on weeks four, six, 12, 18, 26, and 52 for a general physical examination as well as analysis of clinical chemistry, hematology, and urinalysis. Researchers observed no serious adverse events and also found a surprising boost in antibody production, which may forecast success in Phase 2 trials measuring immune response.

The antibody against p24 capsid antigen increased as much as 64-fold in some vaccinees while the antibody against gp120 surface antigen increased up to eight-fold. P24 is a structural protein that makes up most of the HIV viral core also known as the ‘capsid.’ High levels of p24 are present in the blood serum of newly infected individuals during the short period between infection and seroconversion, making p24 antigen assays useful in diagnosing primary HIV infection. A glycoprotein, gp120, is necessary for attachment to cell surface receptors and also allows for the HIV virus to enter cells.

There are so many unanswered questions about this trial. Were the test subjects on HAART? What were their viral loads before and after the injections? Were baselines effected any after receiving the vaccine? Why don't they give us that information? It's what is important in knowing if it'd really work as a therapeutic vaccine. I can only assume that information wasn't provided because it wasn't good news.

There are so many unanswered questions about this trial. Were the test subjects on HAART? What were their viral loads before and after the injections? Were baselines effected any after receiving the vaccine? Why don't they give us that information? It's what is important in knowing if it'd really work as a therapeutic vaccine. I can only assume that information wasn't provided because it wasn't good news.

vaboi; That information wasn't provided because this was a Phase 1 study. The primary objectives of a phase 1 study are to assess the safety and tolerability, which is done on a small group (40 people in this case I believe) and the results are not statistically significant. While they are looking at the immunological response from the phase 1 study the results are really just a "gut check" to confirm that moving to phase 2 warrants the investment - not to draw any scientific conclusions. Stay tuned for phase 2 (which will be 3 - 5 years out, if they get funding relatively quickly).

Excuse the cut and paste but this article appears in Slate today about this "breakthrough vaccine"

Researchers at Western University in Ontario, Canada, announced today that a newly developed HIV vaccine passed the first phase of clinical trials. That’s extremely good news, of course, but it should still be approached with a healthy dose of caution. The announcement doesn’t mean that scientists have discovered an effective vaccine against HIV—and even if they had, such a tool would be far from a silver bullet in the fight against AIDS.

If Western University’s vaccine actually works, it will, without a doubt, change the face of HIV prevention. A vaccine for the virus has been famously elusive; every trial thus far has failed, some disappointingly, some disastrously. The most effective trial produced a vaccine that’s just 31 percent effective, a figure low enough to make further trials impracticable. The worst, without a doubt, ended just last April, when doctors discovered that their vaccine might increase patients’ risk of contracting the disease.

So a vaccine whose effectiveness matched even, say, that of a flu shot (about 60 percent) would be a big deal. But the effectiveness of Western University’s vaccine remains a giant question mark, as researchers took the relatively unorthodox route of testing their shot on already-infected patients. The trial produced encouraging preliminary results: HIV-positive patients began producing exponentially more antibodies to attack HIV-related antigens. In other words, the vaccine kick-started patients’ immune systems, provoking them to fight back against a virus they would normally succumb to. And it did so without producing any adverse effects. That’s certainly auspicious. But it doesn’t necessarily follow that the vaccine will be as effective in preventing HIV-negative people from acquiring the virus. That question will be tested in the trial’s next phases.

In the meantime, it’s best to remain wary of purported HIV cure-alls. Every few months, doctors and scientists announce a purported cure for HIV: flooding newborns with antiretrovirals, say, or transplanting bone marrow. As a rule, these remedies are limited or one-off—not everyone has the luxury of a bone-marrow transplant, after all—but researchers can’t resist extrapolating upon their implications for the broader population. (How often are we told there will be a cure within months?)

Not only that. If the vaccine works, it also means from then on they'll test positive on a HIV antibody test, doesn't it? I can imagine many potential volunteers feeling not too comfortable about that thought...

Producing antibodies does not prove a vaccine works. Every poz people produces HIV-Ab, still they are not efficents at suppressing virus...i'm wondering how neg people should discover if they are protected by their vaccine

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